March 2011 FDA Recall Drug by Luitpold Pharmaceuticals, Inc.
D-1378-2012 - Presence of Particulate Matter

This Class II drug recall was voluntarily initiated by Luitpold Pharmaceuticals, Inc. on March 15, 2011 for the product Drug. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1378-2012

Reason for Recall
Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed.
Initiated
03-15-2011
Reported
06-20-2012
Quantity
30 mL: 2,078,800 vials; 100 mL: 167,100 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
58410
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Luitpold Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide, Puerto Rico, and Abu Dhabi
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-28-2018
Product Description About Product Description
Full technical description of the product.
CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL SINGLE DOSE VIAL, (NDC 0517-2930-25), b) 100 mL PHARMACY BULK PACKAGE (NDC 0517-2900-25), Rx Only, AMERICAN REGENT, INC. SHIRLEY, NY 11967.

Batch or Lot Expiration Information

Lot# 30 mL Lots: 9198, 9252, 9299, 9305, 9402, 9423, 9432, 9553, 9595, 9646, 9681, 9737, 9797, 9831, 0051, 0095, 0362; 100 mL Lots: 9225, 9492, 9711, 0007, 0058